CapSure® PS System
K-Number: K172175 · 2017-08-16
ApplicantSpine Wave, Inc.
Decision Date2017-08-16
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
CapSure® PS System is a medical device manufactured by Spine Wave, Inc.. It received FDA 510(k) clearance on 2017-08-16 under approval number K172175. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CapSure® PS System?
CapSure® PS System is a medical device that received FDA 510(k) clearance on 2017-08-16. It is manufactured by Spine Wave, Inc.. The 510(k) number is K172175.
When was CapSure® PS System approved by the FDA?
CapSure® PS System received FDA 510(k) clearance on 2017-08-16, under approval number K172175.
What company makes CapSure® PS System?
CapSure® PS System is manufactured by Spine Wave, Inc..
What is the FDA product code for CapSure® PS System?
The FDA product code for CapSure® PS System is NKB.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.